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Completed

NCT Number: NCT05167383

Virtual Reality to Reduce Labor Pain

Background and Goal of Study Labor pain remains an area where different analgesia options are looked for, more specifically non-pharmacological remedies are popular. Hypnosis and virtual reality (VR) have been studied with encouraging results. However, until now, the combination of VR and hypnosis (VRH) has not been assessed during labor, although it has shown promising results in other acute pain areas. The VRH4L study will evaluate the efficacy of Virtual Reality Hypnosis (VRH) in reducing pain during labor. Hypnosis is delivered as a standardized therapeutic intervention through virtual reality, using a digital sedation software (AQUA ®, Oncomfort SA).

For this prospective, interventional parallel group, monocentric randomized controlled trial full term women who were planned for an induction of labor at the St-Jean Hospital in Brussels from March to May 2021 were included. Women with complicated pregnancies and patients with contraindications to VR were excluded.

Patients were randomized in two arms. In the VRH group the patients received a 30-minute session of virtual reality hypnosis when in active labor and had access to standard care. Patients in the control group received only standard care.

Primary outcome was the difference in post intervention pain score between the two arms. Secondary outcomes were the difference in pain score 30 minutes after the intervention, vital signs correlated to pain, satisfaction of the experience, interaction with the midwife and prevalence of side effects. Data was analyzed using the student's T test.

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Key information

Conditions

Labor Pain Hypnosis Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Virtual Reality

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Saint-Jean

Brussels, 1000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: ≥ 18 and ≤ 45 years
  • Pregnant with term gestation
  • Willing to adhere to the rules linked to the use of the VRH headset: turning off mobile phone, visit bathroom in advance, no new visitors and no interference of the partner other than when the woman would ask him so
  • Provision of written informed consent
  • Induced labor

Exclusion criteria

  • Complicated pregnancy ( HELLP,…)
  • Scheduled caesarian delivery
  • Receipt of epidural analgesia or opioid painkillers before start active labor phase
  • Low auditory acuity that precludes use of the device
  • Low visual acuity that precludes use of the device
  • Head or face wounds precluding use of the device
  • Schizophrenia
  • Epilepsy
  • Dizziness
  • Non-proficiency in French and/or Dutch (research language)

Treatment and study plan

VRH (Virtual Reality Hypnosis)

Device

Hypnosis is delivered as a standardized therapeutic intervention through virtual reality, using a digital sedation software (AQUA ®, Onfomfort SA).

Standard Care

Behavioral

The standard treatment (ST) for labor pain as used in our hospital contains massage, aquatherapy and postural exercises. This is always available for any woman in labor.

Primary outcomes

  1. Post interventional pain scores

    Time frame: T1(before intervention) and T3 (directly after intervention)

    Primary outcome was the difference in post intervention pain score between the two arms. Difference in Numerical Rating Scale (0 to 10, where 0 is no pain and 10 is maximum pain) pain scores after the intervention between the VRH and Standard care group.

Secondary outcomes

  1. Pain 30 minutes after intervention

    Time frame: T4 (30 min after intervention)

    Measure of Numerical Rating Scale (0 to 10, where 0 is no pain and 10 is maximum pain) after 30 minutes

  2. Maternal heart rate

    Time frame: T1(before intervention) , T2 (During intervention), T3 (directly after intervention) and T4 (30 min after intervention)

    Measured heart rate during and after intervention as an absolute value.

  3. Nausea

    Time frame: T1(before intervention) , T3 (directly after intervention) and T4 (30 min after intervention)

    Nausea and vomiting scores (0-3, 0 = no nausea, 3= nausea and vomiting))

  4. Satisfaction of the mother

    Time frame: T6 (day 1 postpartum)

    Likert scale (-2,0,2) .-2 is very dissatisfied, 1= dissatisfied, 0= not satisfied, nor dissatisfied, 1= satisfied and 2 is very satisfied

Sponsors and collaborators

Lead sponsor

Clinique Saint-Jean, Bruxelles

Other

Registry information

Official study title

A Prospective Randomized Controlled Monocentric Study Evaluating the Impact of Virtual Reality Hypnosis During Labor

Acronym: VRH4L

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 22, 2021
Registry last updated
Jan 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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